MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRELINK; DATA MANAGEMENT SYSTEM

Model Number 71732-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Application Program Problem (2880)

Patient Problem Loss of consciousness (2418)

Event Date 02/26/2024

Event Type  Injury  

Manufacturer Narrative

The customer reported receiving "replace sensor" error message with freestyle libre application.Abbott diabetes care (adc) attempted to replicate the reported issue using similar configuration of samsung galaxy a52 with android operating system 13, 2.10.2.7677.The reported issue was unable to be replicated and the system functioned as intended.There were no issue identified with the freestyle librelink application during replication that would have led to the reported issue.Therefore, the issue is not confirmed.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An error message was reported via email with the adc device in use with samsung a23 galaxy phone with android operating system version 13.The customer received a "replace sensor" error message and was unable to obtain readings.As a result, the customer experienced a loss of consciousness and went to a hospital.The customer had contact with a healthcare professional (hcp) who provided unspecified treatment.Furthermore, it was indicated that the customer was hospitalized for an unspecified amount of time.No further details were provided.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRELINK
• Type of Device: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 18975422
• MDR Text Key: 338547649
• Report Number: 2954323-2024-09921
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71732-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention